U.S. patent application number 17/732992 was filed with the patent office on 2022-08-25 for biological navigation device.
The applicant listed for this patent is LOMA VISTA MEDICAL, INC.. Invention is credited to Gene Duval, Mark Christopher Scheeff, Alexander Quillin Tilson.
Application Number | 20220265127 17/732992 |
Document ID | / |
Family ID | |
Filed Date | 2022-08-25 |
United States Patent
Application |
20220265127 |
Kind Code |
A1 |
Tilson; Alexander Quillin ;
et al. |
August 25, 2022 |
BIOLOGICAL NAVIGATION DEVICE
Abstract
Biological navigation devices and methods are disclosed. The
devices can be used as or to support colonoscopies or endoscopes.
The devices can have longitudinally extensible cells that can be
selectively inflated. The devices can have articulable links. The
devices can be removably attached to elongated elements, such as
colonoscopes or other endoscopes.
Inventors: |
Tilson; Alexander Quillin;
(Burlingame, CA) ; Scheeff; Mark Christopher; (San
Francisco, CA) ; Duval; Gene; (Menlo Park,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LOMA VISTA MEDICAL, INC. |
Tempe |
AZ |
US |
|
|
Appl. No.: |
17/732992 |
Filed: |
April 29, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16255014 |
Jan 23, 2019 |
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17732992 |
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12512809 |
Jul 30, 2009 |
10188273 |
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16255014 |
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PCT/US2008/052542 |
Jan 30, 2008 |
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12512809 |
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60949219 |
Jul 11, 2007 |
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60887319 |
Jan 30, 2007 |
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60887323 |
Jan 30, 2007 |
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International
Class: |
A61B 1/00 20060101
A61B001/00; A61B 1/005 20060101 A61B001/005; A61B 1/01 20060101
A61B001/01; A61M 25/01 20060101 A61M025/01; A61B 1/31 20060101
A61B001/31; A61B 17/00 20060101 A61B017/00 |
Claims
1. A device for navigation through a biological anatomy, the device
having a longitudinal axis extending in a longitudinal direction,
comprising: a first cell configured to expand and contract in the
longitudinal direction and to correspondingly expand and contract
an overall length of the device, wherein the first cell comprises a
first expandable bladder; a second cell configured to expand and
contract in the longitudinal direction and to correspondingly
expand and contract the overall length of the device, wherein the
second cell comprises a second expandable bladder; a third cell
configured to expand and contract in the longitudinal direction and
to correspondingly expand and contract the overall length of the
device, wherein the third cell comprises a third expandable
bladder; and a control coil comprising a plurality of fluid
channels, a first of the plurality of fluid channels adapted to
inflate the first cell, and a second of the plurality of fluid
channels adapted to independently inflate the second cell with
respect to the first cell, wherein the control coil is positioned
at least partially within an inflatable space of first expandable
bladder, the second expandable bladder, and the third expandable
bladder.
2. The device of claim 1, further comprising a fourth cell
configured to expand and contract in the longitudinal direction,
wherein the fourth cell comprises a fourth expandable bladder.
3. The device of claim 1, wherein the first expandable bladder
comprises a first longitudinally expandable bellow.
4. The device of claim 3, wherein the second expandable bladder
comprises a second longitudinally expandable bellow.
5. The device of claim 1, wherein the device has a tool channel
extending longitudinally through the first cell, the second cell
and the third cell.
6. The device of claim 1, wherein the control coil further includes
at least one wire adapted to control steering of the device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Ser. No.
16/255,014 filed on Jan. 23, 2019, which is a divisional of U.S.
Ser. No. 12/512,809 filed on Jul. 30, 2009, which is a continuation
of PCT/US2008/052542, which claims priority to U.S. Provisional
Application No. 60/887,319 filed on Jan. 30, 2007, U.S. Provisional
60/949,219 filed on Jul. 11, 2007 the disclosures of which are
hereby incorporated by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The presented invention relates generally to devices for the
exploration of luminal cavities. One such device example is an
endoscope, which can be used to explore body passages. Such
passages typically include, but are not limited to, the GI tract,
the pulmonary and gynecological systems, urological tracts, and the
coronary vasculature. One application is directed towards the
exploration of the lower part of the GI tract, for example the
large intestine or colon.
2. Description of the Related Art
[0003] Colonoscopy is a diagnostic and sometimes therapeutic
procedure used in the prevention, diagnosis and treatment of colon
cancer, among other pathologies. With colonoscopy, polyps can be
harvested before they metastasize and spread. With regular
colonoscopies, the incidence of colon cancer can be substantially
reduced.
[0004] The anus can provide entry into the colon for a colonoscopy.
The colon extends from the rectum to the cecum and has sigmoid,
descending, transverse and ascending portions. The sigmoid colon is
the s-shaped portion of the colon between the descending colon and
the rectum.
[0005] Colonoscopy typically involves the anal insertion of a
semi-flexible shaft. To typically navigate the colon, the forward
few inches of tip are flexed or articulated as the shaft is
alternately pushed, pulled, and twisted in a highly skill-based
attempt to advance to the end of the colon: the cecum. The medical
professional imparts these motions in close proximity to the anus,
where the device enters. Tip flexure has typically been
accomplished by rotating wheels--one that controls cables that move
the tip right-left, and one that controls cables that move the tip
up-down.
[0006] Colonoscopes typically utilize various conduits or channels.
The conduits or channels often contain elements that enable vision
(e.g., fiber optics, CCD cameras, CMOS camera chips) and lighting
(e.g., fiber optic light sources, high power LEDs (Light Emitting
Diodes)). They have conduits that provide suction or
pressurization, fluid irrigation, the delivery of instruments
(e.g., for cutting, coagulation, polyp removal, tissue sampling)
and lens cleaning elements (typically a right angle orifice that
exits near the camera, such that a fluid flush provides a cleansing
wash).
[0007] Colonoscopes include articulating sections at their tip,
which allow the user to position the tip. These articulating
sections have rigid link bodies that rotate relative to each other
through the use of pins at their connecting joints. As tensile
cables pull from the periphery of the articulating sections, they
impart torques, which rotate the link sections on their pins,
articulating the tip section. The links are usually rotated by two
or four tensile cables.
[0008] Typical commercially available colonoscopes are currently
reusable. However, as disposable and other lower-cost colonoscopes
are developed, these articulatable sections are no longer
practical. Their high part count creates total costs that are
exorbitant for a lower cost, disposable device. The pivot pins can
also fall out, which can create a patient danger. Their design
geometries, while suited for long life, high cost, high strength
metals elements, don't readily suit themselves to the design goals
of lower-cost and more readily mass-produced parts.
[0009] Suction can be utilized to remove debris or fluid. The colon
can be pressurized to reconfigure the colon into an expanded
cross-section to enhance visualization.
[0010] During advancement of the colonoscope through the colon,
landmarks are noted and an attempt is made to visualize a
significant portion of the colon's inside wall. Therapeutic actions
can occur at any time, but are typically performed during
withdrawal.
[0011] Navigating the long, small diameter colonoscope shaft in
compression through the colon--a circuitous route with highly
irregular anatomy--can be very difficult. Studies have shown a
learning curve for doctors performing colonoscopies of greater than
two-hundred cases. Even with the achievement of such a practice
milestone, the cecum is often not reached, thereby denying the
patient the potential for a full diagnosis.
[0012] During colonoscopy, significant patient pain can result.
This is typically not the result of colon wall contact or of anal
entry. The primary cause of pain is thought to be stretching and
gross distortion of the mesocolon (the mesentery that attaches the
colon to other internal organs). This is commonly referred to as
`looping` and is a result of trying to push a long, small diameter
shaft in compression as the clinician attempts to navigate a
torturous colon. While attempting to advance the tip by pushing on
the scope, often all that occurs is that intermediate locations are
significantly stretched and grossly distorted. Due to this pain,
various forms of anesthesia are typically given to the patient.
Anesthesia delivery results in the direct cost of the anesthesia,
the cost to professionally administer, the costs associate with the
capital equipment and its facility layouts, and the costs
associated with longer procedure time (e.g., prep, anesthesia
administration, post-procedure monitoring, and the need to have
someone else drive the patient home). It has been estimated that
forty percent of the cost of a colonoscopy can be attributed to the
procedure's need for anesthesia.
[0013] Cleaning of colonoscopes is also an issue. Cleaning is time
consuming, and lack of cleaning can result in disease transmission.
Cleaning can utilize noxious chemicals and requires back-up scopes
(some in use while others being cleaned). Cleaning also creates
significant wear-and-tear of the device, which can lead to the need
for more servicing.
[0014] It would therefore be desirable to create a system that is
less painful--possibly not even requiring anesthesia--is
significantly easier to use, and does not require cleaning.
[0015] Everting tube systems have been proposed for use as
colonoscopes. However, multiple challenges exist for everting
systems. One typical challenge is the differential speed between
the center lumen and the tip. For example, as the typical everting
tube is advanced, the center lumen of the colonoscope advances 2''
for every 1'' of eversion front advancement. When the center
advances it moves only itself, whereas tip movement advances
material on both sides. Because there is this dual wall material
requirement for tip advancement, two times as much material is
required, so it inherently must travel at half the rate.
[0016] Anything that is in the center of the typical everting tube
is `pressure clamped,` as the tube's inner diameter collapses to no
cross sectional area as the tube is pressurized. This can make it
difficult to try to solve the 2:1 problem in a typical everting
tube by sliding elements in the inner diameter or central
region.
[0017] This 2:1 advancement issue and the pressure clamping can
make it difficult to locate traditional colonoscope tip elements at
the everting tip's leading edge. Given that the tube is often long
and pressurized, it therefore often precludes the ability to create
a functioning center working channel.
[0018] Another issue is internal drag. Material (e.g., tube wall)
fed to the tip can cause increased capstan drag, for example the
overall system advance force can be retarded to the point of
stopping extension.
[0019] Optimal material selection is a highly significant
challenge. The desired structure must have a rare combination of
features: softness, strength, radial stiffness, low thickness,
freedom from leaks, flex-crack resistance, puncture resistance,
appropriate coefficient of friction, the potential for modifiable
geometry as a fired on of length, and appropriate manufacturability
and cost. Monolithic materials have proven insufficient at
providing the variety of requisite specifications.
[0020] It can be difficult to create a system that is of adequately
low stiffness. Larger diameters create higher propulsive forces,
but they also do not typically readily conform to the colon in a
lumen-centric manner and can be overly stiff.
[0021] Historically, several solutions have been suggested. One
involves periodically depressurizing the system then withdrawing
elements so that their leading edges match. This is time consuming
and creates an undesirably non-continuous and geometrically
interrupted procedure. It is also very difficult to create
`correct` undesirable relative motion to a deflated structure that
essentially is no longer a structure. Another approach involves
driving the inner lumen (typically with a special, thicker,
anti-buckle wall). Because it is driven in compression rather than
through pressure, the everting front can be inflated to a lower
pressure such that its pressure clamping forces are less
significant. This approach, augmented by the significant infusion
of liberal amounts of interluminal lubricants, should enable
advance. However, it has yet to be commercialized, it is very
complicated, creates an undesirably larger diameter instrument, has
lubrication leakage issues, and breaks down at longer advance
lengths.
[0022] Additionally, colonoscopic devices have found its notably
challenging to create methods to steer through torturous
geometrics, particularly without undue colon wall stresses and
subsequent mesocolon stretch. Steering kinematics have been an
ongoing challenge--certainly for existing colonoscopes (which
result in `looping`), but also to more effective next-generation
devices.
[0023] Numerous driven tubes have been proposed for colonoscopy.
Some utilize tube inlaid elements driven in compression. Others
utilize tubes that are pressure driven, with their tubes being of
multiple varieties, including the bellows variety, or everting
types, or other stored material varieties, including scrunch, fold,
or spooled versions
[0024] The systems proposed to date have geometries that create
suboptimal steering efficacies. When a tube section's leading edge
then has a steering section more distal, with typically a camera,
lighting source, and working channel exit at the tip, the steering
is less than effective when going around a corner; a situation is
created in which the tip is retroflexed and is pointing in one
desired direction of advance, but the system's advance is in an
exactly opposite direction. The driven section presumes a
vector--typically an axial manner--with the steering tip only
having efficacy as it relates to its interaction with luminal
walls. In a colonoscopy, this wall interaction is undesirable--it
creates unnecessary wall stress and trauma, and can be a
significant contributor to gross wall distortion, known as
looping.
[0025] It would therefore be desirable to have system designs that
enable more lumen-centric steering as the unit is advanced through
colon curvature. Other improvements are also desired.
SUMMARY OF THE INVENTION
[0026] A device for navigating biological anatomy, such as a
biological lumen, for example the GI tract, is disclosed. The
device can be used for treatment and/or diagnosis. For example, the
device can have a visualization element and can be used as a
colonoscope and/or an endoscope. The device can also have a biopsy
element. The device can also resect tissue and/or deliver drugs or
other agents.
[0027] The device can have one or more pressure tubes. The pressure
tube can have wide medical applicability, including, but not
bruited to, endoscopy and the dilation of anatomical
structures.
[0028] The tubes can have a series of individual pressure cells.
The cells can each have one or more inflatable bladders. The
bladder can be a separate bladder within the cell or substantially
concurrent with the cell itself. The bladder can be a volume
configured to receive and exhaust fluid pressure. The bladder can
have a separate cover (e.g., a bag) within the cell. The cells can
have expandable bellows. The cells can have substantially rigid end
plates with flexible (e.g., cloth or film-like) walls. As the cells
are inflated, the device can be sequentially (i.e., cell by cell)
advanced or reversed through the anatomy. The cells can be
naturally fully-extended. The cells can be compressible to
minimized length by applying a vacuum to the bladders of the cell.
When the vacuum is released, the cells can be expanded to a
full-length configuration with a minimal pressure (e.g., due to a
natural resilient expansion of die cell). The minimal pressure
requirement can keep structural requirements low for the cell, as
well as keeping the device stiffness low. Once extended, the drag
of the device against the lumen wall can be high enough to anchor
the device to the lumen wall or other surrounding anatomy, for
example such that the device would not move backwards as the
distill tip is pushed forward.
[0029] The device can have an endoscopic tool articulating section
that can have pins that are integral to the link bodies. The device
can have articulating mechanisms that are low cost, high strength,
low friction, of low pan count, and of readily modifiable geometry.
The components can be made of a wide range of materials, for
example, injection molded from plastics.
[0030] The device can have a reciprocatable section, for example a
reciprocating distal and of the device. The reciprocating section
can be translated back and forth with respect to the remainder of
the device. This reciprocating feature can enable the tip and its
associated elements to move back and forth without the remainder of
the colonoscope moving.
[0031] The device can also have a reciprocating section that can be
steered in any direction and advanced. The remainder of the device
can then be pulled forward internal to the device, thus advancing
the device through the biological anatomy.
[0032] The development of disposable colanoscopes can reduce or
eliminate cleaning costs, cleaning trouble, and the risk inherent
to reused devices. The colonoscope can also be maximally effective
because its use has not been compromised by previous cases and
their inherent stress and wear. Risks that can be reduced include
the risk of poorly cleaned scopes, and the compromised device
efficacy and reliability issues that are inherent to a
field-contaminated high frequency use and reuse system.
[0033] The disclosed system, device or elements thereof can be used
as elements that are combined into dedicated systems, as portions
of dedicated systems (portions that can be reusable and portions
that can be separable on a case-by-case basis, with some reused and
some disposed of, sometimes referred to as `semisposables` or
`resposables`), or as additive elements to existing systems (i.e.,
retrofit devices). Disposable systems can only need to function for
limited life, and they do not have to interface with other
components again and again. Semisposable varieties can utilize a
very high-quality, higher-cost core device portion, and lower cost,
single-use portions. The single use portions can negate the need
for most of typical cleaning, for example for the sheath exposed
portions. Adding to existing systems can leverage large installed
bases, methods, and usage patterns.
[0034] The device can also be used for interventional cardiology,
for example for lesion dilation, as a stand-alone procedure, for
pre-stent deployment (`pre-dil`), for post-stent deployment, as
part of a stem-expansion inflatable structure used as a stem
delivery system, or combinations thereof.
SUMMARY OF THE FIGURES
[0035] FIG. 1 illustrates a variation of the biological navigation
device in a longitudinally contracted configuration.
[0036] FIG. 2 illustrates the biological navigation device of FIG.
1 in a longitudinally extended configuration.
[0037] FIGS. 3a though 3c illustrate variations of the biological
navigation device.
[0038] FIG. 4 illustrates a variation of the biological navigation
device in a longitudinally contracted configuration.
[0039] FIG. 5 illustrates a variation of cross-section A-A of FIG.
4.
[0040] FIGS. 6a and 6b illustrate variations of a transverse
cross-section of the fluid conduit.
[0041] FIG. 7 illustrates the biological navigation device of FIG.
7 in a longitudinally expanded configuration.
[0042] FIG. 8a illustrates a variation of cross-section B-B of FIG.
7.
[0043] FIG. 8b illustrates a variation of cross-section C-C of FIG.
7.
[0044] FIG. 8c illustrates a variation of cross-section D-D of FIG.
7.
[0045] FIG. 8d illustrates a variation of cross-section E-E of FIG.
8c.
[0046] FIG. 9a illustrates a variation of the biological navigation
device and the elongated element in a longitudinally contracted
configuration.
[0047] FIG. 9b illustrates a variation of cross-section F-F of FIG.
9a.
[0048] FIG. 9c illustrates a variation of cross-section G-G of FIG.
9a.
[0049] FIG. 9d illustrates a variation of close-up H-H of FIG.
9c.
[0050] FIG. 10a illustrates a variation of the biological
navigation device and the elongated element in a longitudinally
partially-expanded configuration.
[0051] FIG. 10b illustrates a variation of cross-section J-J of
FIG. 10a.
[0052] FIG. 10c illustrates a variation of cross-section K-K of
FIG. 10a.
[0053] FIG. 10d illustrates a variation of close-up L-L of FIG.
10c.
[0054] FIG. 11 illustrates a cross-section of a variation of the
biological navigation device.
[0055] FIG. 12 illustrates a variation of the articulatable section
of the biological navigation device.
[0056] FIG. 13 illustrates a variation of the link.
[0057] FIG. 14 illustrates a variation of the articulatable section
having the links of FIG. 13.
[0058] FIG. 15 illustrates a variation of the link.
[0059] FIG. 16 illustrates a variation of the articulatable section
having the links of FIG. 15.
[0060] FIGS. 17a and 17b are end and side views, respectively, of a
variation of the articulatable section having the links of FIG. 13
in a maximum articulation configuration.
[0061] FIG. 18 is a partial cut-away view of a variation of
adjacent links.
[0062] FIGS. 19a and 19b are partial cut-away views of a variation
of adjacent links.
[0063] FIG. 20 is an end view of a cable through-hole from the
links of FIGS. 12a and 12b.
[0064] FIG. 21 illustrate partial cut-away views of a variation of
the links of FIGS. 14a and 14b with cables.
[0065] FIGS. 22a and 22b illustrate variations of the articulatable
sections with varying link angulations.
[0066] FIG. 23 illustrates a wireframe view of a variation of a
reciprocatable section and an articulatable section with the
reciprocatable section in an expanded configuration.
[0067] FIG. 24 illustrates a variation of a reciprocatable section
and an articulatable section with the reciprocatable section in a
contracted configuration.
[0068] FIG. 25a illustrates a variation of a method for using the
base.
[0069] FIG. 25b is a schematic view of a variation of the base and
a fluid system.
[0070] FIG. 26 illustrates a method for using the biological
navigation device in a patient.
[0071] FIGS. 27a through 27g illustrate a variation of a method for
using the biological navigation device.
[0072] FIG. 27h illustrates a variation of a method for using the
biological navigation device.
DETAILED DESCRIPTION
[0073] FIG. 1 illustrates a biological navigation device 10. The
device can be used for navigation through a biological anatomy,
such as a biological lumen, for example any or all of the GI tract
(e.g., colon, stomach, esophagus) or cardiovascular vessels (e.g.,
arteries, veins, heart chambers).
[0074] The navigation device can be removably attached or
integrated (e.g., permanently fixed, welded, glued, fused) with an
elongated element 28. The elongated element 28 can be, for example,
an endoscope or colonoscope. For example, the elongated element 28
can be a CF-Q160 series, PCF-160 series, or CF-2T160 series
colonoscope (from Olympus America, Inc., Center Valley, Pa.), a
Pentax EC-series colonoscope (from Pentax of America, Inc.,
Montvale, N.J.), a Fujinon HD Super CCD colonoscope, or a G-5
endoscope (from Fujinon Inc., Wayne, N.J.).
[0075] The device can have a longitudinally expandable tube 12
having one or more longitudinally extensible or extendable cells
14. Each cell 14 can have one or more fluid-tight bladders 16. The
bladders 16 can be individually inflatable and deflatable, making
the cells 14 individually inflatable (e.g., longitudinally
expandable) and deflatable (e.g., longitudinally contractable).
[0076] The cells 14 can have one or more bellows 18 on the outer
walls. The bellows 18 can be longitudinally expandable. The device
can have a tool channel 20. The tool channel 20 can pass
longitudinally through the center of the device. The tool channel
20 can have elastic and/or bellowed walls.
[0077] The tube 12 can have an engineered coefficient of friction
(COF) on both its inner and outer surfaces.
[0078] The tube 12 can have a tube length. The tube length can be
about 1.0 m (40 in.) to about 2.0 m (79 in.), for example about 1.6
m (63 in.). The tube 12 can have a tube outer diameter. The tube
outer diameter can be from about 18 mm (0.71 in.) to about 23 mm
(0.91 in.).
[0079] FIG. 2 illustrates that the cells 14 can be inflated (e.g.,
via inflating the bladders 16). The device can longitudinally
expand, as shown by arrow.
[0080] FIG. 3a illustrates that the device can have a control coil
22 inside or outside the cells 14. The control coil 22 can have one
or more fluid conduits or channels. The control coil 22 can be
configured to individually and independently or concurrently
inflate the cells 14. The control coil 22 can have one or more
wires to control steering of the device.
[0081] FIG. 3b illustrates that each cell 14 can have a single
bellow 18.
[0082] FIG. 3c illustrates that the control coil 22 can have a
first fluid port 42a in a first cell 14 and a second fluid port 42b
in a second cell 14. The first and second fluid ports 42a and 42b
can be in fluid communication with first and second fluid channels
38a and 38b within the control coil 22. Fluid pressure in the first
and second fluid channels 38a and 38b can be individually
controlled by a base unit 46.
[0083] FIGS. 4 and 5 illustrate that the elongated element 28 can
be received inside the tool channel 20. The elongated element 28
can have a distal component 32 at the distal end of the elongated
element 28. The elongated element 28 can have a umbilical 158
extending proximally from the distal component 32. The elongated
element 28 can have a working channel and/or controls (e.g., data
and/or power wires) for lighting (e.g., LEDs), visualization (e.g.,
CMOS), tools, or combinations thereof. The cells 14 can have cell
seals 40 (e.g., o-rings) between each adjacent cell l4 and/or at
the ends oldie cells 14 and/or between the cells 14 and the tool
channel 20 and/or elongated element 28.
[0084] The control coil 22 can be contained within the cells 14.
The control coil 22 can pass from a first cell 14 to a second cell
14.
[0085] FIG. 6a illustrates that the control coil 22 can have
numerous (e.g., about five) fluid channels 38 or conduits. The
channels can have circular cross-sections. The channels can be
arranged equi-angularly around the center of the control coil 22.
Each fluid conduit can be configured to inflate a separate cell
14.
[0086] A first channel can extend along the center of the control
coil 22. Any or all of the channels can be used to supply fluid
pressure to the cells 14 and/or fluid, power, data, tissue samples
or grafts, or combinations thereof to or from the distal component
32.
[0087] FIG. 6b illustrates that the fluid channels 38 can be
transversely or radially elongated. For example, the cross-section
of the fluid channels 38 can be substantially triangular, as shown.
The control coil 22 can have, for example, about 16 fluid
conduits.
[0088] FIG. 7 illustrates that the cells 14 can be inflated.
[0089] FIG. 8a illustrates that in the longitudinally expanded
configuration, the control coil 22 can longitudinally expand. The
control coil 22 can provide structural radial support. Mechanical
manipulation of the control coil 22, for example via one or more
control leads or wires integral with or attached to the control
coil 22, can steer the biological navigation device 10.
[0090] The working channel 36 can be equi-radial to the working
channel port 34 and/or the working channel 36 can have a trumpeting
configuration as the working channel 36 approaches the working
channel port 34.
[0091] FIG. 8b illustrates that the control coil 22 can pass
between adjacent cells 14 without creating direct fluid
communication between the bladders 16 of the adjacent cells 14. For
example, the control coil 22 can be integrated (e.g., jointly
molded) into the cell wall, or surrounded by a control coil 22 seal
(not shown) to minimize or completely prevent fluid leakage between
the adjacent cells 14.
[0092] FIGS. 8c and 8d illustrate that the control coil 22 can have
a fluid port 42 on the side of the control coil 22. One or more
fluid ports 42 can be located on the control coil 22 within each
cell 14. The fluid ports 42 located within a single cell 14 can be
in fluid communication with the same fluid channel 38. For example,
the fluid ports 42 in the first cell 14 can be in fluid
communication with the first fluid channel 78a. The fluid ports 42
in the second cell 14 can be in fluid communication with the second
fluid channel 78b.
[0093] FIGS. 9a and 9b illustrate that a traveler channel 49 can
extend along the longitudinal axis, for example along the elongated
element 28, for example the umbilical 158. The biological
navigation device 10 can have a pressure traveler 44. The pressure
traveler 44 can be slidably received by the cells 14. For example,
the pressure traveler 44 can be threadably slidably received by the
traveler channel 49 in the umbilical 158 which is slidably received
in the tool channel 20 in the cells 14. The biological navigation
device 10 can be configured so the pressure channel can
controllably deliver and/or withdraw fluid pressure to one or more
cells 14, for example causing the cells 14 to longitudinally expand
and/or contract.
[0094] The distal end of the base 46 can have a trumpeted abutment,
for example, to prevent the base 46 (except the proximal stiffener
152 when the proximal stiffener 152 is attached to the base 46)
from entering the anus during use.
[0095] FIGS. 9c and 9d illustrate that the pressure traveler 44 can
have a fluid channel 38. The fluid channel 38 can be a hollow
conduit in the pressure traveler 44. The fluid channel 38 can have
a traveler cap 48 at the distal end of the fluid channel 38. The
pressure traveler 44 can be translated and rotated (i.e., screwed),
as shown by arrows, into and out of the traveler channel 49. The
elongated element 28, for example in the umbilical 158, can have
one, two or more umbilical pressure channels 57 between the
traveler channel 49 and the bladder 16 of the cell 14. The traveler
channel 49 can have a umbilical pressure port 57 opening into each
umbilical pressure channel 56.
[0096] The traveler channel 49 can have a traveler groove 54, for
example forming a helical configuration along the traveler channel
49. The pressure traveler 44 can have one or more traveler rails 52
(e.g., pegs, threads) configured to sealably and/or slidably engage
the traveler groove 54.
[0097] FIGS. 10a and 10b illustrate that the proximal-most cell 14
of the biological navigation device 10 can be longitudinally
expanded or extended, for example by inflating the cell 14. The
pressure traveler 44 can be translated and rotated, as shown by
arrows, further distal (or proximal) along the biological
navigation device 10 after inflating the inflated cell 14. The
pressure traveler 44 can be left in place after inflating the
inflated cell 14.
[0098] FIGS. 10c and 10d illustrate that the pressure traveler 44
can controllably deliver fluid pressure to one or more selected
umbilical pressure ports 57. The pressure traveler 44 can have a
pressure exit port 42. The pressure exit port 42 can be on the side
of the fluid channel 38. The pressure exit port 42 can be placed in
an adjacent position to the umbilical pressure port 57. The fluid
channel 38 can be pressurized by an external pump (e.g., attached
to the proximal end of the pressure traveler 44). The fluid
pressure in the pressure traveler 44 can be delivered through the
pressure exit port 42 and the umbilical pressure port 57, and
through the umbilical pressure channel 56 and into the bladder of
the cell 14.
[0099] The bladder of the cell 14 can be substantially fluid-tight
for each cell 14 when the pressure traveler 44 is not delivered or
withdrawing fluid pressure. For example, the cell seal 40 can form
a fluid-tight seal between the elongated element 28 and the cell
wall. The umbilical pressure channel 56 and umbilical pressure port
57 can be sealed against the pressure traveler 44 when the pressure
exit port 42 is not aligned with the umbilical pressure port
57.
[0100] FIGS. 11 through 24 depict articulatable sections 66 of the
device. The articulatable section 66 can have multiple links 78 and
one or more cables 80 passing al through the links 78. The cables
80 can be used to control the articulation of the links 78. The
links 78 have flanges 84 and flange seats which can enable rotation
and side location of the biological navigation device 10.
[0101] FIG. 11 illustrates that the device can have or be attached
to (e.g., in the elongated element 38) a steerable section, for
example articulating links 78 or an otherwise articulatable section
66. A distal end of the biological navigation device 10 can be
distal to all or a substantial portion of the steerable section.
Alternatively, the distal end of the biological navigation device
10 can be proximal to all or a substantial portion of the steerable
section.
[0102] The articulatable links 78 can be individually and/or
concurrently articulatable.
[0103] The tube 12 can be configured to be an everting tube. The
tube 12 can have stowed tube material at a distal end 58 of the
tube 12. For example, the stowed material can be scrunched,
bunched, folded, otherwise compacted, or combinations thereof. The
folds can be substantially parallel (as shown) or perpendicular to
the longitudinal axis of the tube 12. The proximal end of the tube
12 can be attached to or integral with a tube connector 72.
[0104] The device can have a base 46. The base 46 can have an exit
port 70. The tube connector 72 can be removably attachable to the
base 46 at the exit port 70. For example, the tube connector 72 can
have a tube connector interlock 74 that can removably attach to a
base interlock 76 on the base 46. The interlocks can be a peg,
rail, hole or other receiver, snap, thread, or combinations
thereof. The tube 12 and tube connector 72 can form a cartridge.
The cartridge can seal to a base unit with a fluid seal that is
located in either the base unit or in the cartridge or cassette
(e.g., along the tube connector 72, for example at the tube
connector interlock 74 and/or base interlock 76). The cartridge can
have a substantially disposable product life.
[0105] The base 46 can controllably deliver fluid pressure to the
inside of the tube 12. For example, the base 46 can controllably
deliver pressure independently to the different fluid channels 38
of the device. The base 46 can control the articulating links 78,
for example via one or more control leads, wires, cables 80, or
combinations thereof.
[0106] The distal component 32 of the elongated element 28 can have
a camera or other visualization element 62. The distal component 32
can have one or more elements that enable vision (e.g., fiber
optics, CCD cameras, CMOS camera chips) and/or lighting (e.g.,
fiber optic light sources, high power LEDs (Light Emitting
Diodes)), such as lighting element 64. The distal component 32 can
have the working channel port 34, for example to provide suction or
pressurization, fluid irrigation, the delivery of instruments
(e.g., for cutting, coagulation, polyp removal, tissue sampling)
and lens cleaning elements (typically a right angle tool or orifice
that can exit near the camera, such that a fluid flush provides a
cleansing wash).
[0107] In an exemplary variation, the elements, in order from the
proximal end of the device to the distal end of the device
(including the elongated element 28) can include: the base 46, the
tube 12, the steering mechanism, the distal end of the tube 12, and
the distal component 32, for example, including lighting and vision
and working channel exit.
[0108] FIG. 12 illustrates a variation of the articulatable section
66 of the device. The articulatable section 66 can have multiple
links 78 and one or more cables 80 passing through the links 78.
The cables 80 can be used to control the articulation of the links
78. As tensile cables pull from the periphery of the articulating
sections, the cables 80 can impart torques, which rotate the links
78 on the axes or rotation of the links 78, articulating the
articulatable section 66.
[0109] The links 78 can be rotatable attached to adjacent links 78.
For example, a first link 78a can be attached at a first end to a
second link 78b. The first link 78a can rotate with respect to the
second link 78b only about a first axis. The first link 78a can be
attached at a second end to a third link. The first link 78a can
rotate with respect to the third link only about a second axis. The
first axis can be non-parallel to the second axis. For example the
first axis can be perpendicular to the second axis. The first and
second axes can be non-parallel to a longitudinal axis of the
articulatable section 66. For example, the first and second links
78a and 78b can be perpendicular to the longitudinal axis of the
articulatable section 66.
[0110] FIG. 13 illustrates that the link can have one, two or more
first flanges 84a pointed in a first longitudinal direction. The
link can have one, two or more second flanges 84b pointed in a
second longitudinal direction. The first flanges 84a can each have
at first pivot hole 88. The second flanges 84b can each have a
second pivot hole 90. With adjacent links 78 in an assembled
configuration (as shown in FIG. 13), a pivot pin (not shown) can be
inserted through the pivot holes. The hinges being integral with
the links 78 can eliminate the need for separate hinge pins to
rotate about.
[0111] The link can have flange seats 86. The flange seats 86 can
be configured to receive the flanges 84 from the adjacent links
78.
[0112] The link can have one, two, three, four or more cable
through-holes 92. The cable through holes 92 can be aligned in a
longitudinal direction. The cable through holes 92 can be
configured to slidably receive a control cable, wire, lead, or
combination thereof. Cable through holes 92 that are off-axis from
pin locations can allow for smaller diametrical profiles while
still maintaining large pin surfaces of rotation. This arrangement
can enable pulling dual cables 80 to actuate about a pin axis, with
superior additive forces resulting.
[0113] The link can have a centered link longitudinal axis. The
angle with respect to the link vertical axis 82 between a cable
through-hole and the adjacent pivot hole can be an adjacent
cable-to-pivot hole angle 94. The adjacent cable-to-pivot hole
angle 94 can be from about 10.degree. to about 90.degree., for
example about 45.degree..
[0114] FIG. 14 illustrates an articulatable section 66 constructed
from the links 78 shown in FIG. 13. The articulatable section 66
can be configured in maximum flexion, as shown. The articulatable
section 66 can have a radius of curvature 104 from about 2.5 mm
(0.1 in.) to about 25 mm (1.0 in.), for example about 15 mm (0.6
in.).
[0115] FIGS. 15 and 16 illustrate links 78 that can be attached to
adjacent links 78 without pivot or other pins. The flange on a
first link 78a can be configured to press against the adjacent
flange on an adjacent second link 78b to rotatably attach the first
flange 84a to the second flange 84b. The links 78 can be
longitudinally compressed to remain attached to the adjacent links
78. For example, the compression can be due to tension in the
cables 80 in the cable through-holes 92.
[0116] Each flange can have a nipple 96 and/or nipple seat (not
shown) located on the axis of rotation of the flange. The nipple 96
and/or nipple seat can rotatably attach to the adjacent nipple 96
or nipple seat on the adjacent flange. The nipple 96 can rotatably
interlock into the nipple seat.
[0117] The link can have an adjacent cable hole-to-flange angle 93.
The adjacent cable hole-to-flange angle 93 can be from about
10.degree. to about 90.degree., for example about 45'.
[0118] The cables 80 in the cable through-holes 92a and 92b can be
pulled in combination or alone to induce a controlled articulation
of the articulatable section 66. The multiple cables 80 can be used
to concurrently impart the multiple (shown as two) cables' force on
one side of the rotational axis of the first (or second)
flange.
[0119] FIG. 16 illustrates an articulatable section 66 constructed
from the links 78 shown in FIG. 15. The articulatable section 66
can be free of pins needed for rotation of the links 78.
[0120] FIGS. 17a and 17b illustrate that the articulatable section
66 can form a tight coil without interfering with other turns of
the coil. The links 78 can have offset configurations that allow
them to coil back without hitting themselves. This allows the links
78 to, among other things, create a more dynamic range of
tip-controlled views that are possible for the tip-located vision
system, for example for use with polyp detection.
[0121] FIG. 18 illustrates that the when adjacent links 78 are in
full flexion with respect to each other, the links 78 can have a to
link angulation 98.
[0122] The first link 78a can have a first cable through-hole 92a.
The second link 78b can have a second cable through-hole 92b. When
the first and second links 78a and 78b are at maximum flexion, the
point where first cable through-hole 92a meets the second cable
through-hole 92b can be a cable crimp point 98. The cable 80 in the
cable through-holes 92 can be crimped et the cable crimp point 98,
for example because of the excessive tension and/or compression on
the cable 80 from the cable making a sharp (e.g., acute) angled
turn.
[0123] FIGS. 19a and 19b illustrate that the first cable
through-hole 92a and/or the second cable through-hole 92b can have
first and second circumferential chamfers 102a and 102b,
respectively. The circumferential chamfers 102a and/or 102b can be
radial widening of the cable through-holes, for example at one or
both ends of the cable through-holes 92. When the first and second
links 78a and 78b are in maximum flexion, the first and second
cable through-holes 92a and 92b can have a continuous radius of
curvature 104 between the first and second cable through-holes 92a
and 92b (e.g., a smooth, rounded path). The continuous radius of
curvature 104 can exist, for example, in the plane a motion for the
given adjacent links 78.
[0124] FIG. 20 illustrates an end view of the second cable
through-hole 92b showing the (second) circumferential chamfer 102b
can be larger than remainder of the (second) cable through-hole
92b.
[0125] FIG. 21 illustrates the cables 80 passing through the cable
through-holes 92a and 92b with the smooth, rounded cable crimp
point 98 with adjacent circumferential chamfers 102a and 102b. The
circumferential chamfers 102a and 102b can reduce cable wear, link
wear and friction.
[0126] FIGS. 22a and 22b illustrate that link configuration can be
modulated to achieve varying systems of curvature. The maximum link
angulation 98 can be from about 5.degree. to about 45.degree.. For
examples, FIG. 22a illustrates the maximum link angulation 98 of
about 12.degree.. FIG. 22b illustrates the maximum link angulation
98 of about 24.degree.. The maximum link angulation 98 can also be,
for example, about 15.degree., about 18.degree., or about
21.degree.. Link angles can be consistent within an articulatable
section 66, or they can modulate from link-to-link within an
articulatable section 66. The thickness of the base of the link 78
can be increased to decrease the maximum link angulation 98. The
thickness of the base of the link 78 can be decreased to increase
the maximum link angulation 98.
[0127] The distal end of the device can be distal to all or a
substantial portion of the steering section (e.g., the articulating
links/section). The distal end of the device can be proximal to all
or a substantial portion of the steering section (e.g., the
articulating links/section). The steering section can be in or on
the elongated element 28, the navigation device, a combination
thereof. The various locations of the steering section can, for
example, alter steering kinematics of the device.
[0128] FIG. 23 illustrates that the device can have a
reciprocatable section 110, for example a reciprocating distal end
of the device. The reciprocating section can be translated back and
forth with respect to the remainder of the device. The device can
have a reciprocating actuator to reciprocate the reciprocating
section. The reciprocating actuator can have one or more a
pneumatic actuators (e.g., a dedicated element or as a function of
an inflatable drive sleeve), cables 80, motors, higher pressure
hydraulics, nitinol elements, smart muscle (e.g., electro active
polymers), or combinations thereof. This reciprocating feature can
enable the tip and its associated elements to move back and forth
without the remainder of the biological navigation device 10 and/or
the elongated element 28 moving. This can enable local close-up
inspections and visualization without the need for motion of the
entire biological navigation device. This can enable the ability to
look in a certain direction and to go towards that point, without
the movement of the entire device. This can enable the ability to
assist in reduction and maneuverability, as it enables the ready
ability to extend the tip to then manipulate tissue or move through
tissue, when perhaps such a movement would be cumbersome for the
wholesale system. This can be through a single reciprocating
element, or through multiple elements, such as telescoping tube
sections or bellows 18.
[0129] The reciprocatable section 110 can have a first
reciprocating element 106a that can translate with respect to a
second reciprocating element 106b. The first reciprocating element
106a can have a distal tip 112 at the distal end of the first
reciprocating element 106a. As shown by arrows in FIG. 23, the
first and second reciprocating elements 106a and 106b can translate
away from each other. As shown by arrows in FIG. 24, the first and
second reciprocating elements 106a and 106b can translate toward
each other. As shown in FIGS. 23 and 24, the reciprocatable section
110 can be proximal to the articulatable section 66. The
reciprocatable section 110 can be distal to the articulatable
section 66.
[0130] The reciprocatable section 110 can be steered in any
direction. The remainder of the device can then be advanced in that
direction through the forward motion portion of the reciprocating
element (e.g., the first reciprocating element and the second
reciprocating element can be actuated to translate away from each
other). Once the device has advanced, for example about 1'' per
reciprocation, the reciprocatable section 110 can have utilized the
full value of the extensibility of the reciprocatable section 110.
The tip can then stay where it is as the umbilical 158 is released
at a rate equivalent to the tip reciprocating rate. Given that
these rates are equivalent, they can--when coupled to a system that
is of high local buckling strength and environment engaged--result
in a tip distal point that is stationary, `reset`, and ready for
the next advance.
[0131] The device can be configured to move With automation
algorithms, for example through motor controls with the motors
being either in the base 46 (e.g., connected to cables 80 in the
tip) or with motors locally in the distal end of the device.
Advancement of the device can be algorithm controlled. For example,
if a section of the target biological lumen is substantially
straight, the device can be translated without inchworming so the
forward advancement of the device can be controlled exclusively by
other translational techniques. (e.g., releasing the umbilical 158
and/or translating the base 46 and/or tube 12 forward). As the
distal tip 112 enters a torturous region, the device can begin
inchworming motions. The inchworming motion can be used, for
example, around corners of the target biological lumen. The distal
tip extension can be highly controllable, steerable and reliable,
and the equal and opposite motions can be difficult to control
during unautornated (e.g., purely manual) use. Further the device
can advance without the need for the typical anchors: radially
expanding members, potentially damaging shear point, or
suction.
[0132] The device can rely on internally produced reciprocating
motion. The device can use its own mass that is simply lying
against the colon surface as a reaction to assist the forward
advancement of the device.
[0133] Electrical wires to the distal component 32 and the distal
tip 112 can be configured to minimize banding of the wires. For
example, the wires can have service loops of flexible wire members
(e.g., including flex circuits). The working channels 36 and fluid
conduits 38 can maintain their continuity and can be leak free. The
working channels 36 and fluid conduits 38 can have compressible
members (e.g., bellows 18), and/or sliding members (e.g.,
telescoping sealed tubes).
[0134] The tension between the links 78 in the articulatable
section 66 can be variably controlled. For example, the tension
applied by the cable between the links 78 can be completely or
substantially minimized to cause the links 78 to go limp. Causing
the links 78 to go limp can snake the links 78 more readily pulled
through the tube 12.
[0135] FIG. 25a illustrates that a pump 144 having an extensible
displacement component 148, such as a piston, can be used to
pressurize the base 46. The piston or otherwise extensible
displacement component 148 can be manipulated to control load
volume to exert a corresponding pressure out of the exit port 70
and into the pressurizable tube 12 of the navigation device. The
piston can minimize stored system energy. A fluid supply 118 can he
attached to the base pressure port 122, for example via connecting
tubing 120. The inlet port can have a one-way (i.e., check) valve
preventing backflow. The exit port 70 can have a one-way (i.e.,
check) valve preventing backflow. The fluid supply 118 can be
filled with fluid. The fluid can be delivered to the deployment
system under no pressure or positive pressure. The fluid can be
air, saline, water, carbon dioxide, nitrogen, or combinations
thereof. The pump 144 can be separate from or attached to the base
pressure port 122. For example, the fluid supply 118 can be routed
through the pump 144 before or after passing through the base
pressure port 122 and into the base.
[0136] FIG. 25b illustrates that the base can be in fluid
communication with a fluid control system 124. The base, for
example at the base pressure port 122, can be connected to a
pressure delivery line 140. The pressure delivery line 140 can be
connected to an outgoing second valve 136 and/or an incoming first
valve 126.
[0137] The first valve 126 can be configured to open manually
and/or automatically. The first valve 126 can open when the tube
pressure exceeds a maximum desired tube pressure. The first valve
126 can be connected to a vacuum pump 128. The vacuum pump 128 can
be activated to deflate the tube 12 and withdraw the tube 12 or
reduce the tube pressure. The vacuum pump 128 can be attached to an
exhaust tank and/or directly to a bleed or drain line 132. The
exhaust tank 130 can be connected to the drain line 132, for
example to exhaust overflow from the exhaust tank 130.
[0138] Controls 134 can be in data communication with the first
valve 126 and the second valve 136. The controls 134 can be on the
base (e.g., a button or switch on the base).
[0139] The second valve 136 can be attached to a pump 144, for
example a cylinder 146 with a displacement component 148, such as a
piston. A pressure regulator 138 can be in the flow path between
the pump 144 and the second valve 136. The pressure regulator 138
and/or the first valve 126 can open and release pressure from the
pump 144 when the tube pressure exceeds a maximum desired tube
pressure.
[0140] An intake tank 142 can be fed in line (as shown) or through
the pump 144 to the second valve 136, for example through the
pressure regulator 138. The fluid in the intake tank 142 can be fed
into the pressurized tube 12. The intake tank 142 can have a fill
line 150 for filling the intake tank 142 with fluid. The fill line
150 can be fed directly to the second valve 136, pressure regulator
138 or pump 144 without the intake tank 142.
[0141] The biological navigation device 10 can have capital
equipment which can provide utility to the remainder of the device.
The capital equipment can include, for example, the elements in the
fluid control system 124. The fluid control system 124 can have a
fluid source (e.g., the intake tank 142 and/or fill line 150), a
pressurize source such as the pump 144, a conduit for delivery of
the pressurization media (e.g., the pressure delivery line 140),
controls 134, system monitoring elements (e.g., can be in the
controls 134). The capital equipment can reduce the profile or the
tube 12, for example, in which tools can be inserted. The
integrated tools can create elements that reduce waste, thereby
allowing for higher value capture and less refuse.
[0142] The fluid pressurization can be controlled by a variety of
user inputs, for example a button on the elongated element 28 or
base, voice commands, foot pedals, or combinations thereof.
[0143] FIG. 26 illustrates that the base can be handheld. The base
can have a proximal stiffener 152 or introducer. The proximal
stiffener 152 of the base can be inserted into the anus 154. The
base pressure port 122 can be connected to a pressure source, such
as the pump 144 and/or a fluid supply 118, before or after
inserting the proximal stiffener 152. The base can be attached to
the tube 12 (not shown, as the tube 12 is in the patient).
[0144] The anus 154 can provide entry into the colon 156 for a
colonoscopy. The colon 156 extends from the rectum 160 to the cecum
and has sigmoid, descending, transverse and ascending portions. The
sigmoid colon 162 is the s-shaped portion of the colon 156 between
the descending colon 164 and the rectum 160.
[0145] A colonoscopy can include inserting the proximal stiffener
152 and/or elongated element 28 into the anus 154. To navigate the
colon 156, the forward few inches of the proximal stiftner 152 or
the elongated element 28 can be flexed or steered and alternately
pushed, pulled, and twisted. Once inserted, the biological
navigation device 10 can navigate to the end of the colon 156: the
cecum 170.
[0146] FIG. 27a illustrates that the biological navigation device
10 can be positioned before entry into the colon 156, for example
via the rectum 160 after passing the anus 154. FIG. 25b illustrates
that the pressure in the distal-most cell or cells 14 can be
increased and/or the biological navigation device 10 can be
otherwise deployed. The biological navigation device 10 can
translate, as shown by arrow, into the rectum 160, attached to the
elongated element 28.
[0147] The biological navigation device 10 is shown having an outer
diameter smaller than the inner diameter of the colon 156 for
exemplary purposes. The biological navigation device 10 can have an
outer diameter about equal to the inner diameter of the colon 156.
For example, the tube 12 can flexibly expand to substantially fill
the cross-section of the length of the colon 156 occupied by the
biological navigation device 10.
[0148] FIG. 27c illustrates that the distal end of the biological
navigation device 10 can actively or passively flex in a `cone of
motion`, with one portion of that plane of motion depicted by the
arrow. The distal end of the biological navigation device 10 can
actively rotate, for example by actuation of one or more control
wires and/or actuators in or attached to the distal component 32 or
head, such as the articulating section and/or control coil 22
described supra.
[0149] The distal end of the biological navigation device 10 can
passively rotate, for example if the biological navigation device
10 (e.g., the tube 12 and/or the distal component 32) contacts a
wall of the colon 156 (e.g., the superior wall of the rectum 160),
the biological navigation device 10 can then track to the wall of
the colon 156.
[0150] FIG. 27d illustrates that after making a turn in the rectum
160, the distal end of the biological navigation device 10 can be
fort her extended, as shown by arrow, or translated into, and
through the sigmoid colon 162, for example as additional cells 14
are inflated and longitudinally expanded. The cells 14 can be
expanded in or out of longitudinal order (i.e., most distal to most
proximal). For example, the two most distal cells 14 can be
alternately inflated and deflated to inchworm or help loosen or
ease navigation of the distal end of the biological navigation
device 10.
[0151] FIG. 27e illustrates that the biological navigation device
10 can make a turn, as shown by arrow, for example as the
biological navigation device 10 passes from the sigmoid colon 162
to the descending colon 164. FIG. 43f illustrates that the
biological navigation device 10 can be further advanced, extended
or translated, as shown by arrow, for example by inflating
additional cells 14, through the descending colon 164 after the
biological navigation device 10 has made two previous turns.
[0152] The biological navigation device 10 can be repeatedly turned
and advanced, for example by inflating the cells l4 and/or
controlling the articulatable section 66 and/or the elongated
element 28 otherwise, to extend as far along the colon 156 as
desired.
[0153] At any length in the colon 156, the biological navigation
device 10 or elongated element 28, for example at the distal
component 32 of the elongated element 28, can gather diagnostic
(e.g., sensing) data, such as data for visualization, tissue
inductance, RF absorption or combinations thereof. The biological
navigation device 10 and/or elongated element 28 can also gather
tissue samples (e.g., by performing a biopsy or removing a polyp).
At any length in the colon 156, the biological navigation device 10
and/or elongated element 28, for example at the distal component
32, can perform treatment or therapy such as delivery of a drug
onto or into tissue, tissue removal (e.g., polyp or tumor removal),
or combinations thereof.
[0154] FIG. 27g illustrates that the biological navigation device
10 can be advanced along the entire colon 156, passing through the
rectum 160, sigmoid colon 162, descending colon 164, transverse
colon 166, ascending colon l68, and having the tip distal end in
the cecum 170. The biological navigation device 10 can be
withdrawn, as shown by arrows, from the colon 156, for example by
applying a tensile force against the tube 12 and/or elongated
element 28, as shown by arrows 172 and/or deflating the cells 14.
The biological navigation device 10 can be withdrawn, as shown by
arrows, from the colon 156, for example by applying a tensile force
to the umbilical(s) 158.
[0155] FIG. 27h illustrates that the cells 4 at the proximal end of
the biological navigation device 10 can be inflated or otherwise
extended before the cells 14 at the distal end of the biological
navigation device 10. For example, the cells 14 can be sequentially
inflated or extended from the proximal-most cell 14 to the
distal-most cell 14 (also as shown in FIG. 10a). Alternatively, the
cells 14 can be sequentially inflated or extended from the
distal-most cell 14 to the proximal-most cell 14 or in an order not
in a sequential order of the cell 14 location along the length of
the biological navigation device 10.
[0156] The biological navigation device 10 can be manually and/or
actuator controlled. Control inputs can be delivered through a
manually actuated controllable module, such as a joystick (e.g.,
for tip control) and/or a series of linear and rotary
potentiometers and switches. The biological navigation device 10
can be programmed to be controlled by voice commands. The
biological navigation device 10 can be controlled by a foot pedal
(e.g., for tube extension or translation), and/or a combinational
interface (e.g., baud controlled), for example for tip control. The
user interface can be attached as part of the biological navigation
device 10, and/or the user interface can be a control unit that is
attached by wares to the biological navigation device 10, and/or
the user interface can communicate wirelessly with the remainder of
the biological navigation device 10.
[0157] Any or all elements of the biological navigation device 10
and/or other devices or apparatuses described herein can be made
from, for example, a single or multiple stainless steel alloys,
nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g.,
ELGILOY.RTM. from Elgin Specialty Metals, Elgin, Ill.;
CONICHROME.RTM. from Carpenter Metals Corp, Wyomissing, Pa.),
nickel-cobalt alloys (e.g., MP35N.RTM. from Magellan Industrial
Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g.,
molybdenum TZM alloy, for example as disclosed in International
Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein
incorporated by reference in its entirety), tungsten-rhenium
alloys, for example, as disclosed in International Pub. No. WO
03/082363, polymers such as polyethylene teraphathalate (PET),
polyester (e.g., DACRON.RTM. from E. I. Du Pont de Nemours and
Company, Wilmington, Del.), polypropylene, aromatic polyestem, such
as liquid crystal polymers (e.g., Vectran, from Kuraray Ltd.,
Tokyo, Japan), ultra high molecular weight polyethylene (i.e.,
extended chain, high-modulus or high-performance polyethylene)
fiber and/or yarn (e.g., SPECTRA.RTM. Fiber and SPECTRA.RTM. Guard,
from Honeywell International, Inc., Morris Township, N.J., or
DYNEEMA.RTM. from Royal DSM N.V., Heerlen, the Netherlands),
polytetrafluoroethylene (PTEE), expanded PTFE (ePTFE), polyether
ketone (PEK), polyether ether ketone (PEEK), poly ether ketone
ketone (PEKK) (also poly aryl ether ketone ketone), nylon,
polyether-block co-polyamide polymers (e.g., PEBAX.RTM. from
ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g.,
TECOFLEX.RTM. from Thermedics Polymer Products, Wilmington, Mass.),
polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated
ethylene propylene (FEP), absorbable or resorbable polymers such as
polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic
acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL),
polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino
tyrosine-based acids, extruded collagen, silicone, zinc, echogenic,
radioactive, radiopaque materials, a biomaterial (e.g., cadaver
tissue, collagen, allograft, autograft, xenograft) any of the other
materials listed herein or combinations thereof. Examples of
radiopaque materials are barium sulfate, zinc oxide, titaniwn,
stainless steel, nickel-titanium alloys, tantalum and gold.
[0158] The systems, devices, elements and methods disclosed herein
can be used in conjunction or substituted with any of the systems,
devices, elements and methods disclosed in Provisional Patent
Application Nos. 60/887,323, filed 30 Jan. 2007; and 60/949,219,
filed 11 Jul. 2007; U.S. Patent Application titled "Biological
Navigation Device", attorney docket number LMVSNZ00200, filed
concurrently herewith; and PCT Application tided "Biological
Navigation Device", attorney docket number LMVSNZ00500WO, filed
concurrently herewith, which are all incorporated herein by
reference in their entireties, The everting element can be merely
representative of any pressurized tube 12, including those
disclosed in the references incorporated, supra.
[0159] The term colonoscope is used for exemplary purposes and can
be any deployable elongated element 28 for use in a body lumen,
such as an endoscope. The pressurizer can be the deployment system.
The terms tip, tool tip, tip distal end, and tool head are used
interchangeably herein.
[0160] The tube 12 can have wide medical applicability, including,
but not limited to, endoscopy and the dilation of anatomical
structures. One such dilation application is for use in the field
of interventional cardiology, where they can be used for lesion
dilation, as a stand-alone procedure, for pre-stent deployment
(`pre-dil`), for post-stent deployment, as part of a
,stent-expansion inflatable structure used as a stent delivery
system, or combinations thereof.
[0161] Any elements described harem as singular can be pluralized
(i.e., anything described as `one" can be more than one). Any
species element of a genus element can have the, characteristics or
elements of any other species element of that genus. The
above-described configurations, elements or complete assemblies and
methods and their elements for carrying out the invention, and
variations of aspects of the invention can be combined and modified
with each other in any combination.
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